CAPECITABINE
- Product NDC
- 16714-468
- 11-digit product format
- 167140468
- Labeler code
- 16714
- Product ID
- 16714-468_d6937464-feb2-ada0-e053-2a95a90a3aef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CAPECITABINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NORTHSTAR RXLLC
- Application
- ANDA202593
- Marketing category
- ANDA
- Marketing start
- 2015-11-01
- Marketing end
- 0000-00-00
- Substance
- CAPECITABINE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CAPECITABINE | ACTIVE INGREDIENT | 6804DJ8Z9U | CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| CAPECITABINE | ACTIVE MOIETY | 6804DJ8Z9U | CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-468 | CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] | 6 | Legacy NDC | 20241204_7b260da3-dee2-4bbb-9235-39b16720d578.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16714-468-01 | 16714046801 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-468-01) | 2015-11-01 | 0000-00-00 | No | No | Current |